MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM 4.0 CONSOLE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NIM4CM01
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: n im4cpb1, serial/lot #: (b)(6), ubd: , udi#: (b)(4); product id: nim4cpb1, serial/lot #: (b)(6), ubd: , udi#: (b)(4) h6: img code g2005 belongs to product id: nim4cpb1 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that pre op the device was beeping and making a bunch of noise when the pi box is plugged in to the console.Tried 3 other pi boxes, and 2 made the noises.The system displays an out of measurement range message without excessive noise.Troubleshooting done by site: swapped between wired/wireless connection, swapped pi boxes, complaint not resolved, swapped console, complaint not replicated, confirmed system is in its own isolated outlet.Troubleshooting by rep: replicated issue with her own pi box, replicated with site's pi boxes, confirmed no other console is experiencing this issue there was no patient impact.

• Brand Name: NIM 4.0 CONSOLE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 25370847
• Report Number: 1045254-2026-00773
• Device Sequence Number: 10655277
• Product Code: GWF
• UDI-Device Identifier: 00763000395896
• UDI-Public: (01)00763000395896(11)220817
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K200759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NIM4CM01
• Device Catalogue Number: NIM4CM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown